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临床试验/NCT07464548
NCT07464548招募中不适用

Determining the Effects of Stoma Education on Patients' Self-Efficacy, Body Image, and Stoma Adherence

Munzur University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Stoma Adjustment

研究概览

简要总结

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not have information regarding group assignments. Due to the nature of the study, information about the educator who administered the intervention will not be provided. To minimize potential bias, outcome evaluation and data analysis will be performed by individuals who do not have information about group assignments.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults who have undergone colostomy or ileostomy surgery.
  • •Willingness to participate voluntarily in the study.
  • •Elective surgery patients.
  • •No diagnosed psychological disorders.

排除标准

  • •Emergency surgery cases.
  • •Patients with cognitive impairment or psychiatric disorders preventing participation.
  • •Patients unwilling to participate or unable to comply with study follow-ups.

研究组 & 干预措施

Control Group

No Intervention

Group receiving standard clinical training

Intervention Group

Other

Teach-Back Education :Nursing intervention Intervention Type: Behavioral Intervention Name: Stoma Care Education Program "No drug or device is used in this intervention."

干预措施: Teach-Back Education (Other)

结局指标

主要结局

Stoma Adjustment

时间窗: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge

Participant's adjustment to living with a stoma, assessed using a validated stoma adjustment scale at each follow-up. The Stoma Adjustment Scale is a psychosocial assessment tool developed to evaluate the extent to which individuals with stomas have adjusted to their new lives. The scale consists of numerous items that assess an individual's body image, social life, daily activities, ability to manage stoma care, and emotional adjustment, and is commonly used by stoma nurses and researchers. Items are scored using a Likert-type rating scale, and individuals are asked to indicate their level of agreement with each statement. Each item is generally scored from 1 to 6; a score of 1 indicates low adjustment, and a score of 6 indicates high adjustment. The scores of the items on the scale are added together to obtain a total adjustment score. A higher total score indicates better adjustment to the stoma and living with a stoma, while lower scores suggest that the individual may experience

次要结局

  • Body Image(Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge)
  • Self-Efficacy(Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilgün SÖYLEMEZ

Munzur University

Munzur University

研究点 (2)

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